SONOST 3000.pdf

SONOST 3000 User’s Manual

Model: SONOST 3000 Council Directive 93/42/EEC Concerning Medical Device

http://www.osteosys.com OsteoSys Co., Ltd.

User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R0422-00-MUL

OT00-2F0423-01 A4(210 × 297)

２

SONOST 3000 User’s Manual

Software Version : 3.03.06 Document Version : 4.00

Document Number : OT06-2R0422-00-MUL

Manufacturer and EC Authorized Representative Information

♣ Manufacturer : OsteoSys Co., Ltd. 3F, 308, Byucksan Digital Valley3rd, 212-13, Guro-Dong, Guro-Gu, 152-848, Seoul, Korea Tel : 82-2-2025-1650 Fax : 82-2-2025-2299

♣ EC Authorized Representative : Ecornet Medical GmbH High-t' Part Mainstr. 6c-d,D-45768, Marl, Germany Tel : 49-2365-92-437-0 Fax : 49-2365-92-437-55

CAUTION !

1. You must be well acquainted with this manual before using it. 2. This manual should be placed where the user could read it whenever

necessary.


OT00-2F0423-01 A4(210 × 297)

３

Thank you for purchasing SONOST 3000 Ultrasound Bone Densitometer.

To ensure safe operation and long-term performance stability, it is essential that you fully understand the functions and operating, maintenance instructions by reading this manual before operating the equipment. Particular attention must be paid to all warnings, cautions and notes incorporated herein.

Incorrect operation, or failure of the user to maintain the equipment

relieves the manufacturer or his agent of the system’s noncompliance with specifications or of responsibility for any damage or injury.

The following conventions are used throughout the manual to denote information of special emphasis.

WARNING !

“Warning” is used to indicate the presence of hazard that can cause severe personal injury, death or substantial property damage if the warning is ignored.

CAUTION !

“Caution” is used to indicate the presence of hazard that will or can minor personal injury and property damage if the caution is ignored.

NOTE !

“Note” is used to notify the user of installation, operation or maintenance information that is important but not hazard related.


OT00-2F0423-01 A4(210 × 297)

４

The symbols which are shown in this manual or SONOST 3000

The noticed information which should be concerned with explanation in this manual

The noticed information when the device is operated

The reference page or section

Applied Part Type BF

I and O on power switch represent ON and OFF, respectively

The Attention symbol that marks warning and important information in the user’s manual

The conductor provides a connection between equipment and the potential equalization bus-bar of the electrical installation

The date of manufacture

This symbol indicates “caution” for the hot surface.


OT00-2F0423-01 A4(210 × 297)

５

Table of Contents Chapter 1. Introduction ................................................................................................. 7 Chapter 2. Configuration of Device .............................................................................. 9

2.1 Composion of Device ......................................................................................... 9 2.1.1 Shape and Components of Device ........................................................... 9 2.1.2 Accessories List ....................................................................................... 10 2.1.3 Articles List ............................................................................................ 1 1

2.2 Installation of SONOST 3000 ......................................................................... 12 2.3 Before Turning on Power ................................................................................ 13

Chapter 3. Using SONOST 3000 ................................................................................. 14 3.1 Using H/W ........................................................................................................ 14

3.1.1 Patient Measurement Procedure........................................................... 14 3.1.2 Where and How Much Apply to the Patient's heel ............................. 15 3.1.3 Correct Position for Patient's Foot & Body ......................................... 16 3.1.4 Setting of Internal Printer………...…………………………………...17

3.2 Using S/W ........................................................................................................ 2 0 3.2.1 Progress Table of Program ................................................................... 2 0 3.2.2 Execution of Program ........................................................................... 2 1 3.2.3 Setting of the Incipient Environment……………………………..….2 2 3.2.4 Measurement of Bone Mineral Density(BMD Measurement) .......... 2 8 3.2.5 Revision and Deletion of Patient's Information ................................. 3 2 3.2.6 Inquiry and Deletion of Clinical History of Existing Patients .......... 3 3 3.2.7 Calibration of SONOST 3000(DailyTest) ............................................ 3 4 3.2.8 Printing of clinical history and Result ................................................. 3 6

Chapter 4. Maintenance and Repair of SONOST 3000 ........................................... 3 8 4.1 Resolution to Problems ................................................................................... 3 8 4.2 Maintenance and Repair ................................................................................ 3 9

4.2.1 Cleaning, Disinfection, Sterilization .................................................... 3 9 4.2.2 Product's Life ......................................................................................... 3 9 4.2.3 Stockpile and Replacement of Articles ................................................ 4 0 4.2.4 Storage .................................................................................................... 4 0

4.3 Safe Use of SONOST 3000 ............................................................................. 4 1 4.3.1 Safety Rules ............................................................................................ 4 1 4.3.2 Cautions Related to Use Electronic Medical Equipment .................. 4 2

Chapter 5. Specifications & Software Updates ...................................................... 4 7


OT00-2F0423-01 A4(210 × 297)

６

5.1 Specifications ................................................................................................... 4 7 5.2 Software Updates ............................................................................................ 4 9

Chapter 6. Reference ................................................................................................... 5 0 6.1 Definition of Parameter Terminology ........................................................... 5 0 6.2 Reference Data ................................................................................................ 5 2

Chapter 7 . Product Warranty ................................................................................... 5 3


OT00-2F0423-01 A4(210 × 297)

７

Chapter 1. Introduction

Osteoporosis is one of the serious diseases. This device is a bone densitometer which estimates a bone mineral density of the calcaneus by ultrasound.

The measurement site is the calcaneus. It takes about 1 minute to measure

the density and to display the shape of ultrasonic wave by computing simulation on the monitor.

To ensure safe operation and long-term performance stability, it is essential

that you fully understand the functions, operating and maintenance instructions reading this manual before operating the equipment.


OT00-2F0423-01 A4(210 × 297)

８

※ Features and Cautions !

- This device is an ultrasound bone densitometer which has ±0.2(T-score) precision error.

- The equipment must be operated only by, or under supervision of a

qualified person.

- When you give the appropriate commands in SONOST 3000 software, ultrasonic waves are generated. The generated ultrasonic waves pass through the Patient’s calcaneus and the electric signal is treated by SONOST 3000 algorithm.

- All operators must understand the potential hazards in the use of

medical electronic devices. They must be able to recognize hazards and protect themselves and others from injury.

- The system should be placed at least 20cm from the wall.

- Never remove any system covers.

- In case of changing the printer for other products, check them

according to IEC/EN60601-1-1.

- Unplug the power cord after using.


OT00-2F0423-01 A4(210 × 297)

９

Chapter 2. Configuration of Device 2.1 Composition of Device

2.1.1 Shape and Components of Device

1-1

1-2

1-31-4

1-5

1-6

1-7

NO

Name Function

1-1 TOP COVER Protection for internal circuit

1-2 CALF SUPPORT Leg fixation for diagnosing

1-3 PROBE Generation of ultrasound

1-4 LCD Display for measuring status

1-5 THERMAL PRINTER Thermal printing for the measurement report

1-6 SWITCH PANEL Connection for the power cord and power ON/OFF switch

1-7 EXTERNAL CONNECTOR

USB Port for printer, keyboard and mouse


OT00-2F0423-01 A4(210 × 297)

１０

NOTE !

Use external device which certificated by standard (IEC-60601-1).

NOTE !

Use Accessory which defined at user‘s manual.

2.1.2 Accessories List

Check the following accessories before installing the system. If they are not in good condition, contact to OsteoSys or its authorized dealer for this service.

Names of Products

Number Uses

User’s Manual 1 Make sure to keep it at a designated place so that users can read it anytime they need to.

Foot Positioner 3 Use them in accordance with patients’ foot size.

QC Phantom 1

It is used to calibration the system.

Keep it in the specified place and protect it against deformation by heat or pressure.

Power Cable 1

It is used to connect to the source of electric power with the main body of SONOST 3000.

Make sure to connect it with a grounded electric outlet.


OT00-2F0423-01 A4(210 × 297)

１１

2.1.3 Articles List

Check the following accessories before installing the system. If they are not in good condition, contact to OsteoSys or its authorized dealer for this service

4.2.2 Stockpiles and Replacement of Articles

Names of Products Number Uses

Ultrasound Gel 2 bottles It helps ultrasound to progress between a probe and patient’s heel.

Alcohol 1 box It removes some material which prevents ultrasound from progressing.

Printer Paper 2 rolls Result paper is printed at printer paper. Minimum paper thickness : 0.07mm


OT00-2F0423-01 A4(210 × 297)

１２

2.2 Installation of SONOST 3000

NOTE ! Since SONOST3000 is made up of precise components, you should install the

product according to instructions below. Do not install and keep SONOST3000 at excessively high or low temperatures. Proper temperature: 18~27 ℃

Do not install or keep SONOST3000 in the place where the machine can be rocked or shaken. Make sure to place the system parallel to the floor.

Do not install the system in the place with polluted air and high humidity and do not expose the machine to direct ray sunlight. It is advisable to use SONOST3000 in the place equipped with air conditioning or heating. Proper humidity: 20~80%

Install SONOST3000 in the place where it is free from water or chemicals.

Do not share the power outlet with other products through an extension cord.

For escaping from electronic noise, do not install near a electronic generator, X-ray equipment, broadcasting equipment. It causes a result to be inaccurate.

Do not cover ventilation of the system or place it near the wall. High inside temperature of the machine might cause a fire.

100-240V is usable. When SONOST3000 is taken out of a warehouse, insulating transformers should be set to 100-240V. Since sudden power outage can remove all data saved in the product, you should install SONOST3000 in the place where a power supply is stabilized.


OT00-2F0423-01 A4(210 × 297)

１３

2.3 Before Turning on Power

Connection of Power Cable(with the outlet)

CAUTION !

Make sure that the covering of cable is not damaged to prevent electric shock or short circuit.

If you find any damage or any sign of it, immediately contact an agency.

Put the Power cord into only one plug

Make sure not to share the power outlet to prevent SONOST 3000 from being affected.


OT00-2F0423-01 A4(210 × 297)

１４

Chapter 3. Using SONOST 3000 3.1 Using H/W

3.1.1 Patient Measurement Procedure

Clean the surface of the

Coupling Pad with an alcohol and apply gel enough.

Clean the both side of patient’s

heel with an alcohol pad and apply

gel.

Insert patient’s foot. Let a patient move his foot up to

down just like this picture. Start to measure after insertion.


OT00-2F0423-01 A4(210 × 297)

１５

NOTE !

Insert patient’s foot after widen probe’s gap enough, because probe pad is made from soft silicon.

3.1.2 Where and How Much Apply to the Patient’s Heel

Before measuring, using alcohol to rub patient’s heel : protection for removing air bubbles surface of patient’s skin and other infections. Apply plenty of ultrasound gel to both side of patient’s heel

Good

No Good


OT00-2F0423-01 A4(210 × 297)

１６

3.1.3 Correct position for Patient’s foot & body

Adhere a heel to the measuring device closely as shown 3 points below.

Make sure measuring device and body should be one line as shown below.

Patient

Device


OT00-2F0423-01 A4(210 × 297)

１７

3.1.4 Setting of Internal Printer

Paper type : Thermal paper width 58mm. thickness : MIN 0.07mm (About 80 reports are printable by one roll)

Paper character : Only printable in an outer surface Purchasing : Purchase from the headquarters or an agency. Paper inserting

① Cover opening : Pull-down open the dark gray cover on the device’s the back side

② Paper inserting : Insert the paper as shown below.

Outer surface of paper should face to the inside of the device.

Paper is scrolled in automatically.


OT00-2F0423-01 A4(210 × 297)

１８

③ Cover shutting : Put the paper to the gap in the cover, then shut the cover up.

⑥ Paper cutting : For a sharp outline of report printing, cut off the remained

paper once by a saw tooth in the cover.

CAUTION !

Do not touch the metal part of the thermal printer head. The hot surface may cause to burn.


OT00-2F0423-01 A4(210 × 297)

１９

3.2 Using S/W

3.2.1 Progress Table of Program

Start

Print History Print Result

Home

Patient List

History List

Measure

Result

Dailytest

Setup

ProductInformation

Start Measure

Add Patient

Search Patient

Modify Patient

Delete Pateint

Delete History


OT00-2F0423-01 A4(210 × 297)

２０

3.2.2 Execution of Program

CAUTION !

If you hear any strange noise from the screen, switch it off and contact to OsteoSys or its Authorized dealer.

Turn on the power switch.

10 seconds after calibration that checks functions of the system and memory device, the program is automatically activated and you should configure the incipient environment.

This is the incipient screen.

Home of the incipient screen There are Main buttons on the top line, It is used when the screen is moved. The bottom line is consisted of Sub buttons, it is use for sub function. Other screens are similar formation.

- QuickMeasure : Direct measuring function without patient’s registration process. - DailyTest : Daily test function.

When the daily test is needed, the color of button is red. After it is need not, the color of button is turn to same with others.

- Setup : Consists of functions which are related with program setting. - Information : Display information about the program and device.


OT00-2F0423-01 A4(210 × 297)

２１

3.2.3 Setting of the Incipient Environment

Click the <Setup>button on the Home Screen, then environment window is appeared.

Setup Window

- <Settings> : Fundamental settings related Software. - <System> : Settings related Operating System. - <Cleaning> : It makes probe is moved of user’s own accord for cleaning. - <Backup> : Control of measured data. - <Patch> : Software upgrade.

Settings

It makes fundamental settings related Software.

Setup>Settings Window


OT00-2F0423-01 A4(210 × 297)

２２

- Hospital Name : Insert the hospital name which will be on the report. - Default Scan Site : Select the default scan site when measure. - Default Gender : Choose the gender when insert the patient’s information. - Default Ethnicity : Choose the ethnicity when insert the patient’s

information. - DailyTest Interval : Fix the interval of daily test - Default Printer : Choose the internal thermal printer or external general

printer. * External general printer will be supported later on.

- Ink-Economic Mode : Choose the Ink-Economic mode when use the external printer.

- : Setup printer. System

It makes settings related Operating System.

Setup>System Window

- System Date/Time : Present time setting. It becomes standard for patient’s registered date, measured date and printed date. Fix the time and click the <Save>button.

- Touch Panel calibration : It is used when the touch panel is out of order.

Read the screen message carefully, then press the arrow indicated point exactly.


OT00-2F0423-01 A4(210 × 297)

２３

Cleaning

It makes probe is moved of user’s own accord for cleaning.

Setup>Cleaning Window

- Narrow : It makes narrow the probe’s interval - Stop : It makes the probe stop. - Widen : It widen the space of two probes.

Backup

It controls the measured data.

Setup>Backup Window

- Export : If you click this button, you can export data to USB memory stick or external printer.


OT00-2F0423-01 A4(210 × 297)

２４

Setup>Backup>Export Window

All : Export all data. By period : Export data within a selected period of time. Individual : Export selected patient’s data. * Destination : You can select USB Memory Stick or Printer.

(But, If you are select ‘Individual’, you can’t select printer)

Clear : If you click this button, you can clear data.

Setup>Backup>Clear Window

All : Clear all data. By period : Clear data within a selected period of time.

- Import : If you click this button, you can import the exported data.


OT00-2F0423-01 A4(210 × 297)

２５

Setup>Backup>Import Window

Patch

It is upgrade the Software.

Setup>Patch Window At first, Prepare a USB removable disk which support USB 1.1. You can use mp3 player or digital camera too. Copy the patch file(file name : NK.BIN) to USB removable disk. Insert USB removable disk into SONOST 3000 device’s USB port.


OT00-2F0423-01 A4(210 × 297)

２６

Click File open button . And select the patch file. (Generally, USB removable disk is “Hard Disk2” folder) Click Patch button. Cursor is changed to a sandglass. Patch takes 5-10 minutes. When patch is finished, “Patch Complete” message is occurred. Restart SONOST 3000. You can confirm by seeing software information at Home>Information.

NOTE !

During patch, if you turn off device or take USB removable disk off, Critical problem will be occurred.


OT00-2F0423-01 A4(210 × 297)

２７

3.2.4 Measurement of Bone Mineral Density (BMD Measurement)

Patient Registration and Search

If you click the <patient>button on the top line at the incipient screen, you can move to “Patient List” which display and control the registered patient Left list mean registered patient’s birth year. If you click the year, you can see the patient’s ID and name list were bone in the same year.

Patient List Window

If you want to register a new patient, then click the <Add>button on the bottom line. Then “Add Patient” window is appeared which insert the patient’s information.

If you insert and click the <Ok>button, then patient is registered and displayed on the screen.

Add Patient Window - PatientID : Insert the ID which can identify the patient.


OT00-2F0423-01 A4(210 × 297)

２８

(64 characters are MAX) - Name : Insert the patient’s name. (64 characters are MAX) - Year of Birth : Insert the patient’s year of birth. - Gender : Insert the patient’s gender. - Ethnicity : Insert the patient’s ethnicity. - Foot Supporter : Choose the Foot Supporter according to the foot size.

If you want to search the registered patient, click the <Search>button on the bottom line and make it appear the “Search Patient” window. It apply search condition of the patient’s ID, name, gender and year of birth.

If you insert the related information and click the <Ok>button, then the result is displayed on the screen.

Search Patient Window

Search Result Window


OT00-2F0423-01 A4(210 × 297)

２９

Measurement of Patients

If you want to measure the patient’s Bone Density, select a desired patient in the Patient List screen and click the <Measure>button. Then the “Measure” screen appears as shown below.

Measure Screen

Click the <Start>button on the bottom of left. Then the message box inquiring measuring site and so on. If you select inquiring articles and click the <Ok>button, ultrasound waves are generated from the probe.

Select Site Window

When ultrasound waves are generated, the <Start>button is changed into <Stop>button. In case of emergency, click this button, and you can stop measuring. In the normal condition, ultrasound waves generation is finished


OT00-2F0423-01 A4(210 × 297)

３０

about 15 seconds after, then the “Measure Complete” window is appeared with the alarm sound.

If you click the <Ok> button, the detailed results is displayed as shown below.

Detailed results screen.

If you click the <Print>button on the bottom of results screen, then the report is printed.

Printed Report


OT00-2F0423-01 A4(210 × 297)

３１

3.2.5 Revision and Deletion of Patient’s Information

Revision of Patient’s Information

If you want to revise the registered patients’ information, select a desired patient and click the <Modify>button on the bottom.

Then the “Modify Patient” screen appears as shown below, in this condition, if you enter a new value to make desired changes in the patient’s information and click the <OK>button, the patient’s information is revised.

Modify Patient Window

Deletion of Patient’s Information

If you want to delete the registered patients’ information, select a desired patient in the “Patient List” screen and click the <Delete>button on the bottom.

Then the message box “Delete Patient” inquiring about the whether to delete the information surely appears and if you click the <OK> button, the information is deleted.

Delete Patient Window


OT00-2F0423-01 A4(210 × 297)

３２

3.2.6 Inquiry and Deletion of Clinical History of Existing Patients

Inquiry of Clinical History of Existing Patients

If you want to retrieve the clinical history of existing patients, select a desired patient and click the <History>button on the top of the “Patient List” screen.

Then “History List” screen appears that contains the patient’s clinical history as shown below. On the right side, the left and right foot’s measurement results list shows. If you select a measurement result in the list, the relevant clinical history represented by a graph on the left side.

History List Screen

Detailed Representation of Clinical History of Existing Patients

If you click the <Detail>button on the “History List” screen, the detailed result of the selected patient appears in the full screen.

Detailed Result Screen


OT00-2F0423-01 A4(210 × 297)

３３

Deletion of Clinical History of Existing Patients

If you want to delete the clinical result of patients, select a desired result and click the <Delete>button on the bottom of the result screen. Then the message box “Delete History?” that inquiring about whether to delete the result or not appears. If you click the <OK>button, the result is deleted.

Delete Patient Window


OT00-2F0423-01 A4(210 × 297)

３４

3.2.7 Calibration of SONOST 3000(DailyTest)

DailyTest

Make sure to calibrate the system to reduce a margin of error and to get accurate value in times of examining bone density. It is to raise credibility of examination results through checking of system reliability on a daily basis.

To calibrate the system, click the <DailyTest>button in the “Home” screen.

Then the “DailyTest” screen appears as shown below. When you click the <StartDailyTest>button, DailyTest is started. If the DailyTest success, the message box “Complete Dailytest” appears and back to “Home” screen.

If you select the “Time” tap, graph appears in the time domain. If you select the “Frequency” tap, graph appears in the frequency domain.

DailyTest Screen

Whenever you calibrate the system, you should use the QC Phantom included in the accessories list.

If you click the <Start>button on the bottom, ultrasonic waves are generated

and the word on the <Start> button is changed into <Stop>. In case of emergency, click this button and you can stop daily testing. In the normal condition, the message box “Complete Dailytest” appears as shown below with an alarm sound after progressing calibration of the system and if you click <OK>button, the progress of calibration is completed.


OT00-2F0423-01 A4(210 × 297)

３５

NOTE !

In case of the screen shows the calibration has failed, do not use the system and execute “DailyTest” once again. If calibration fails continually, contact to OsteoSys or its authorized dealer.


OT00-2F0423-01 A4(210 × 297)

３６

3.2.8 Printing of clinical history and Result

SONOST 3000 support inner printer(thermal printer) and external printer(normal USB printer). (If the selected model is exclusive use of external printer. Inner printer will not be provided.)

Inner Printer (Thermal Printer) Inner printer is affixed on the device back inside. It will be able to use without software setting.

Printed result paper

External Printer (Normal Printer) SONOST 3000 use a general USB support printer as external printer. It is required to setup printer in detail, because a kind of external printer various.


OT00-2F0423-01 A4(210 × 297)

３７

- Printer : Selection of printer. - Port : Selection of port. (Must select LPT1.) - Paper Size : Selection of paper size. - Draft Mode : Selection of print quality (Checked : Low Quality, No

checked : High Quality) - Color : Selection of color or gray

Printed result paper


OT00-2F0423-01 A4(210 × 297)

３８

Chapter 4. Maintenance and Repair of SONOST 3000

4.1 Resolution to Problems

If SONOST 3000 shows following symptoms, check the system as follows.

Problems Checking Points

SONOST 3000 is not activated with the power on.

Is the device properly plugged?

Isn’t the power cord damaged?

Result of calibration of the system turns out to be abnormal

3.2.6 Calibration of SONOST3000

Result of measurement turns out to be abnormal

3.2.4 BMD Measurement 3.2.7 Calibration of SONOST3000

Despite measurement according to the instructions, its result turns out to be abnormal

Is the desired part of the body properly placed?

4.2.1. Cleaning, Disinfection, Sterilization

CAUTION !

If you cannot resolve the problem, contact to OsteoSys or its authorized dealer.


OT00-2F0423-01 A4(210 × 297)

３９

4.2 Maintenance and Repair 4.2.1 Cleaning, Disinfection, Sterilization.

CAUTION !

Turn off the power before cleaning the device.

Product Instructions

Device

After using the device, wash with water. The device should be cleaned with a water wringed clean soft cloth everyday, because gel remains around the probe or below the device. Especially, gel stained on the probe should be removed. After this procedure, clean the stained area with a dry piece of cloth. Probe endurance condition

Temperature range : -40℃~70℃ Humidity 0~90% Atmospheric pressure : 50~106kPa External force 0~1N

Make sure not to put water or detergent on the device directly because it can cause fatal damage in the electric circuit contained inside.

4.2.2 Product’s life

This product’s life is 7 years. (Except Accessory)


OT00-2F0423-01 A4(210 × 297)

４０

4.2.3 Stockpile and Replacement of Articles

Make sure to keep following articles of consumption all the time.

2.1.3 Articles List

Articles Specifications

Gel Gel is a necessary article when measuring BMD. Please purchase new one before it being out of stock.

4.2.4 Storage

Daily Storage

- Unplug the power cord. - Dust on the product can damage the system. After use, make sure

to cover it with a vinyl cover. - If the hardened gel remains in the device, it can effect on BMD results. Please clean the device everyday.

4.2.1 Cleaning, Disinfection, Sterilization

Storage for a long time period

- Unplug the power cord. - Put cover on the product to avoid dust. - Keep the product according to instructions described in “2.2

Installation of SONOST 3000”

2.2 Installation of SONOST 3000


OT00-2F0423-01 A4(210 × 297)

４１

4.3 Safe Use of SONOST 3000

4.3.1 Safety Rules

The followings are instructions for safe use of the product Make sure to comply with the instructions when you activate the system.

Refer to “4.3.2 Caution related to electronic medical equipment”

4.3.2 Cautions Related to Use of Electronic Medical Equipment

CAUTION !

Do not open it because there are some high-tension components inside. It might cause serious danger.

Check if the cable coating is not damaged before

turning on the system to prevent electric shock or leakage of electricity. If it is damaged or broken, immediately contact an agency.

Do not share the power outlet with other products.

If you share the outlet it will affect the product.

CAUTION !

Read user’s instructions carefully before using the

product. Place the user’s instructions at a designated place

so that users can read it anytime they need it. If you hear a strange noise or if you find any

abnormality on the LCD screen after turning on the product, contact the headquarters or an agency.

Make sure to turn off the power switch before

cleaning the product.


OT00-2F0423-01 A4(210 × 297)

４２

4.3.2 Cautions Related to Use Electronic Medical Equipment Safety rules described below are based on Paragraphs 495 of laws and

ordinances promulgated by Ministry of Welfare of Japan. The safety rules pertain to use of electric medical equipment. Read them carefully for safe use of the product and make sure to refer to “4.3.1 Safety rules”

4.3.1 Safety Rules

１ Nobody can handle SONOST 3000 except for doctors and authorized personnel

２ Comply with followings in times of installation of SONOST 3000. Do not

install it in following places. A) Places where the product is exposed to water vapor B) Places where the product is exposed to spray or splashing water. C) Places where the product is exposed to high density oil vapor D) Places where the product is subject to excessive shocks or vibrations. E) Places where the angle of inclination of the mounting surface exceeds 10

degrees. F) Places where air pressure, temperature or humidity drastically changes. G) Places exposed to direct sunlight or places where air is polluted due to dirt, salt

and sulfur H) Places where chemicals are kept or toxic gas is leaked. I) Places where the AC power line voltage fluctuates heavily J) Places where the AC power line voltage fluctuates heavily while this product is

operating. K) Places where there is a ventilation problem. L) Do not lean, shake or rock the product during transportation. M) Adjust frequency, voltage or current to the product. N) The product is portable but make sure to put a brake on it when you stop the

product. O) Ground the product by using ground wire. P) Do not share the power outlet.


OT00-2F0423-01 A4(210 × 297)

４３

３ Check followings before using the product. A) Whether power is off before putting a plug in the socket. B) Whether the power supply line is suitable with that of the system

(AC 100~240 V) C) Whether the system is fully grounded. D) Whether all the connection parts(power and optional equipment) are connected

with the system properly.

2.3 Before Turning on Power

E) The product has been factory-set for optimum performance. Do not attempt to adjust any preset controls or switches except for operation as specified in this manual.

F) If you experience any trouble with the product, turn it off immediately and contact OsteoSys or its authorized dealer for assistance.

G) Before electrically or mechanically connection any other manufactures’ devices to SONOST 3000, contact OsteoSys or its authorized dealer for instructions

H) Do not operate the product improperly when you use it with other products. I) Make sure to check whether external parts of the device directly touches the

patient. J) Make sure to check whether the products keep distances at least 20cm from

walls.

CAUTION !

Equipotential Bonding

In hospital, doctors and patients are subjected to dangerous, uncontrollable

compensating currents. These currents are due to the potential differences

between connected equipment and touchable conducting parts as found in

medical rooms. The safest solution to the problem is accomplished is consistent

equipotential bonding. Medical equipment is connected with connecting leads

made up with angle sockets to the equipotential bonding network in medical

rooms.


OT00-2F0423-01 A4(210 × 297)

４４

NOTE !

Try to place the system far from power generators, X-ray machines, broadcasting stations, and transmission lines to avoids electrical noise during scanning. Otherwise, abnormal images may result. An independent circuit and a safely grounded outlets are strongly recommended for SONOST 3000. Poor or abnormal images may occur if the system shares a power source with other electrical or electronic equipment.

NOTE !

The classification according to standard IEC/EN 60601-I - Type of protection against electric shock : Class I - Degree of protection against electric shock : Type B - Degree of protection against harmful ingress of water : IPX 0 - Methods of sterilization or disinfection : See Chapter 4.2.1 - Not suitable for use in the pressure of flammable anesthetic mixtures

４ Check followings while the device is in operation. A) Whether the product and the patient are normal B) Whether the products keep distances with one another C) If you find any abnormality related to the product or patient, stop its operation

and check if it can cause any danger to the patient.


OT00-2F0423-01 A4(210 × 297)

４５

D) If the fuses are gone, exchange the same type (250V T315AL). Otherwise a fire may occur or you may receive electric shock.

NOTE !

Fuse Replacement

1.Open the fuse drawer on the upper side of the appliance inlet, there will be the two small fuse holder.

2.Push the fuse holder toward the arrow direction, and Pull the fuse holder toward the upper side of the appliance inlet.

3.Remove the old fuse by pulling up 4.Install the new fuse by pushing to the fuse holder.

5.Insert the fuse holder to the appliance inlet. At this time, the arrow direction in the upper side of the fuse holder should be in accordance with that on the fuse draw.

6.Also, the same method is used to exchange the other fuse folder. 7.Close the fuse the drawer.

CAUTION !

For continuous protection against a risk of fire hazard, replace only with same type and same rating of fuse.


OT00-2F0423-01 A4(210 × 297)

４６

５ Checking points after use of product

A) Make sure to clean the product so that use Deactivate the product and turn the power off in order.

B) Do not pull the power cord forcibly. C) Comply with followings to keep the product properly. ① Avoid places that can wet the product. ② Avoid places where air pressure, temperature and humidity drastically

change and where there are direct ray of sun, dirt, salt and sulfur. ③ Do not lean, shake or rock the product.

D) Clean accessories after use. E) Make sure to clean the product so that users can use it immediately

６ If the product is out of order, do not try to repair it for yourself. ７ Do not modify use the product. If any modification is desired, ask OsteoSys or

its authorized dealer for this service. ８ Check, maintenance and repair ９ Cautions in times of transportation of cart

If you have to move the cart on incline floor, you should detach the product from the cart so that the product does not slip to the ground.

１０ Environmental protection If the products are at the end of their useful lives, do not dispose them at your option. Contact OsteoSys or its authorized dealer for this service.

１１ Others

Read the user’s instructions carefully and use the product properly.


OT00-2F0423-01 A4(210 × 297)

４７

Chapter 5. Specifications & Software Updates

5.1 Specifications

*General

Classification ClassⅠ, Type BF Applied part

*Device

Dimensions 615mm × 293mm × 310mm

Weight 12Kg

Input Voltage AC 100V ~ 240V,

Free Voltage (Single Phase)

Input Current 1A, Class I

Frequency 50/60Hz

Power 300W max.

Ultrasonic Probe Diameter Ø25mm

Ultrasonic Center Frequency 0.55MHz

Ultrasonic Probe Position Setting Variable Measurement 25~100mm

Patient’s Measurement Posture In a sitting posture

Accessory QC Phantom


OT00-2F0423-01 A4(210 × 297)

４８

Operating Temperature

*Environmental

10 ~ 40℃

Transport / Storage Temperature -10 ~ 70℃

Operating Humidity 30 ~ 75% relative humidity

Transport / Storage Humidity 0 ~ 90% relative humidity, non-condensing

Atmosphere 700 ~ 1060 hPa

Shock Not to exceed 2G in six millisecond

Dust, Fumes, Airborne debris

Install system in a clean, well-ventilated area. Excessive dust and other airborne debris contaminants can impair sensitive parts. We recommend instituting a “No Smoking” policy in system area.


OT00-2F0423-01 A4(210 × 297)

４９

5.2 Software Updates

1. Updates to SONOST 3000 software are available at our

homepage (http://www.osteosys.com).

2. Updates to SONOST 3000 software are free, regardless of

the product warranty.

3. Updates to SONOST 3000 software are irregular, we will

inform you through your email whenever SONOST 3000

software needs to be updated.

4. For details, call the OsteoSys Co., Ltd customer service

department or your OsteoSys Co., Ltd distributor.

http://www.osteosys.com/�


OT00-2F0423-01 A4(210 × 297)

５０

Chapter 6. Reference 6.1 Definition of Parameter Terminology BUA(Broadband Ultrasound Attenuation)

Parameter which reflect bone density and structure by reduction analysis of ultrasound pulse intensity which through the bone.

SOS(Speed Of Sound) Velocity of ultrasound wave through the bone which reflect bone mineral density

BQI(Bone Quality Index) Generally SOS is in proportion to the temperature, and BUA is in inverse proportion to the temperature. These correlation coefficients are (α, β) combined for as shown below. This Parameter which is represented constant number compensates the precision error from the temperature. The relation between age and BQI (Refer to the picture)

BQI = α x SOS + β x BUA

T-Score Average BQI in twenties(Young adult), that is BQI standard deviation in twenties.

1) More than -1 : Normal 2) -1 ~ -2.5 : Osteopenia 3) -2.5 and below : Osteoporosis

T- Score’s meaning in the view of probability T-Score represents the patient’s BQI above or below a reference “Young

adult” mean and is expressed in standard deviation(SD) units. Therefore, If patient’s BMD value makes normal distribution shape, then

T-Score means in the view of probability as below.

1) T < -6, T > +6 : 2 of 1,000,000,000 persons 2) T < -5, T > +5 : 3.8 of 100,000,000 persons


OT00-2F0423-01 A4(210 × 297)

５１

3) T < -4, T > +4 : 6.3 of 10,000 persons 4) T < -3, T > +3 : 2.7 of 1,000 persons 5) T < -2, T > +2 : 4.6 of 100 persons

For example, Person in T<-3 exist 1.35 ratio of 1,000 persons in whole population.

Z-Score Average BQI in the same age, that is BQI standard deviation in the same age. 1) More than 0 : BMD is higher than the average of the same age. 2) 0 : Average value of the same age. 3) 0 and below : BMD is lower than the average of the same age.

Explanations of BUA Measurement MODE Terminology 1)PEAK : Maximum value of signal in the frequency domain. 2) Center Frequency : Value of center frequency. 3) Percent : % Bandwidth(3dB bandwidth ÷ Center Frequency × 100) Generally, as these values are lower, BUA values is higher.

Explanations of SOS Measurement MODE Terminology 1) Zero Point : Cross point of the time Ox which is used for acquiring the

signal’s position. 2) Gain : Amplification degree of ultrasonic signal which is controlled

automatically. 3) Peak : Maximum value of signal in the time domain. 4) TOF(Time Of Flight) : Elapsed time of ultrasonic signal from transmission

to reception. It is used for SOS calculation.


OT00-2F0423-01 A4(210 × 297)

５２

6.2 Reference Data Reference Data

We achieved reference data from several group with different environment in Korea. And the data is analyzed by statistical method.

Ages 20~24 25~29 30~34 35~39 40~44 45~49 50~54 55~59 60~64 65~69 70~74 75~80 Mean 100.0 102.5 104.1 98.9 95.7 89.3 83.2 81.0 79.3 77.7 74.7 74.2

SD 15.3 19.0 15.9 15.9 12.0 15.6 12.5 10.5 12.7 11.6 12.7 12.5 N 40 38 35 38 40 42 37 41 35 37 38 35 Where we make the BQI(Bone Quality Index) by weighting sum of SOS,

BUA


OT00-2F0423-01 A4(210 × 297)

５３

Chapter 7 . Product Warranty • Scope and Period of Warranty

(1) OsteoSys Co., Ltd. guarantees all new product against faults in materials or workmanship for a period of one year from date of shipment to purchaser. OsteoSys Co., Ltd. will, as sole and exclusive remedy, at no charge, replace any such defective unit returned to its service designated warranty period.

(2)This warranty applies only to failures from operating the product under

conditions for which it was designed. Warranted product is to be used only for the intended and labeled indications presented in the literature accompanying the product.

(3)OsteoSys Co., Ltd. will charge service fees in following cases.

-If the product is out of order after the warranty period expires. -If the product is out of order due to natural disasters such as fire, flood,

windstorm, hail, lightning and earthquake. -If the product is out of order due to improper transportation after

installation and careless use. -If the product is out of order due to improper repair or renovation by

someone other than service personnel of the company.

(4) Cosmetic defects or deterioration will not be refinished or replaced. The costs of replacement of fuses are not covered.

(5) OsteoSys Co., Ltd. will not be responsible for any loss, damage, or injury

resulting from delay in rendering service under this warranty.

(6) OsteoSys Co., Ltd. will not be responsible to you for incidental or consequential damages of any kind arising from or connected with the use of its equipment.


OT00-2F0423-01 A4(210 × 297)

５４

• What Should be Noted in Times of Request of Repair

(1) If the product is out of order, stop using it and read the manual carefully. (2)Before you request for repair, switch off the product and contact a

designated service agency after checking the name of model, serial number and date of purchase. OsteoSys Co., Ltd. will replace the defective product at no cost to you. OsteoSys Co., Ltd. will pay the shipping and insurance costs of product sent to you.

(3)Defective equipment shipped from you to OsteoSys Co., Ltd. must be packed

in the replacement cartons. Shipping and insurance costs for the return of the defective product must be pre-paid by you.

(4)If you request the product information to repair the defective product

yourself, we provide you with the proper information.

• This limited is in lieu of all other warranties expressed or

implied, including warranties of merchant ability or

fitness for any particular use. No representative or other

person is authorized to represent or assume for OsteoSys

Co., Ltd. any warranty liability beyond that set forth

herein.

SONOST 3000.pdf

Documents

Transcript of SONOST 3000.pdf